Efficacy of a Patient Education Video

July 17, 2015 updated by: Virginia Commonwealth University
Patients in the intervention arm will view the 23-minute video depicting the Hematopoietic stem cell transplantation (HSCT) experience. Patients in the control arm will receive HSCT frequently asked questions (FAQ) sheet developed by the National Cancer Institute (NCI) at the National Institutes of Health (NIH).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study's overall goals are 1) to improve outcomes; and 2) to increase satisfaction with the physician consultation.

Patients will be randomized to intervention or control and data will be collected at three time points (before treatment, 30 days post-HSCT and 12 months post-HSCT).

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cancer patients scheduled for HSCT

Exclusion Criteria:

  • Patients who have received HSCT previously
  • Patients who do not speak English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video
Patients will view the 23-minute "Guide to Stem Cell Transplantation" video depicting the HSCT experience
Behavioral: Video
23-minute video
Other Names:
  • Guide to Stem Cell Transplantation
Active Comparator: FAQ Sheet
Patients will receive HSCT FAQ sheet developed by the NCI at the NIH
Behavioral: FAQ Sheet
Other Names:
  • HSCT Freuently asked questions sheet developed by NCI at NIH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in emergency department visits
Time Frame: Up to 12 months after HSCT
Data will be collected through review of medical and insurance billing records
Up to 12 months after HSCT
Change in number of hospitalizations
Time Frame: Up to 12 months after HSCT
Data will be collected through review of medical and insurance billing records
Up to 12 months after HSCT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perception of satisfaction with the physician consultation
Time Frame: Up to 12 months after HSCT
The Physician consultation will be measured by the Patient Satisfaction Communication Questionnaire (PSCQA). Participants are asked to rate their experience with the physician consultation. There are 17 items, 8 positively worded and 9 negatively worded. Each item is rated on a 5 point likert scale with 1 being strongly agree to 5 being strongly disagree. The maximum score on the PSCQ is 85. The measure takes approximately 4 minutes to administer.
Up to 12 months after HSCT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Investigators

  • Principal Investigator: Robin K Matsuyama, PhD, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

April 3, 2014

First Submitted That Met QC Criteria

April 14, 2014

First Posted (Estimate)

April 15, 2014

Study Record Updates

Last Update Posted (Estimate)

July 21, 2015

Last Update Submitted That Met QC Criteria

July 17, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-13-10228
  • HM20000410 (Other Identifier: Office of Research Subject Protection)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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